Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related field.
Must have 5 years of experience in job offered or a related position.
Must have 3 years of experience in the following: FDA regulated industry experience; total engineering project experience including leading CAPA Process Using DMAIC
methodology, root cause analysis utilizing efficient root cause tools, and experience with project management tools such as Gantt chart, Project Burn down charts; risk Determination; FMEA Analysis; performing product and process containment activities; process and Product Non-conformance investigations; developing feasible and impactful solutions; and Verification of effectiveness planning.
Must have 2 years of experience with the following: Applying statistical analysis for quality control/assurance and CAPA Verification of Effectiveness plan (Statistical based sampling, Capability Studies, Null Hypothesis Testing, Design of Experiments (DOE); preparing, Reviewing and approving CAPA Metrics and Quality system records in a manner complaint with 21 CFR Part 820 & part 11 regulations and ISO13485; ability to Demonstrate leadership and lead team meetings; ability to influence people with decisions and make critical quality decisions; Interviewing and Onboarding new Team members; create CAPA Training material and Coach team members across organization on the training material; ability to lead Kaizen event, CAPA Review Board meetings and internal audits; and ability to lead quality Circles.
Must have experience with the following: ISO quality systems auditing; Presenting to a non-technical audience; Providing training to a technical audience; and Lean Manufacturing projects.
Location: Biomet Manufacturing, LLC (formerly Corp.), 56 E Bell Drive, Warsaw, IN 46582